Natural Killer Cells (NK cells) are a group of immune cells with a CD3-CD56+ phenotype, which are usually found in lymph nodes, various organs and peripheral blood. NK cells account for about 5-20% of the peripheral blood lymphocytes of the human body, thus the peripheral blood is one of the suitable sources for obtaining NK cells. Due to the insufficient number and cytotoxicity of NK cells collected directly from the peripheral blood, therefore it is necessary to increase the number and cytotoxicity of NK cells by ex vivo expansion before being used for treatment.
Natural Killer (NK) cells originate from hematopoietic stem cells (CD34+ stem cells) and share a common lymphoid progenitor cell with T cells and B cells. However, unlike T cells and B cells, NK cells do not express the characteristic markers of T cells (CD3 and T Cell Receptor) or B cells (CD19 and CD20). They are an essential component of the innate immune system.
In the 1970s, NK cells were discovered to have the unique ability to kill cancer cells without the need for prior sensitization or education, a process known as priming. This intrinsic ability led to their designation as “natural killer” cells. Subsequent research has shown that NK cells can also kill cells infected by viruses, transformed cells, and stressed cells, such as those that are aging or under cellular stress.
NK cells can kill cancer cells through the following mechanisms:
(i) secreting perforin and granzyme to induce apoptosis of cancer cells.
(ii) the death ligand binds to the death receptor on the surface of cancer cells to trigger the apoptosis of cancer cells.
(iii) secreting cytokines such as TNF-α and IFN-γ to regulate the functions of immune cells, such as T cells and dendritic cells, thereby strengthening the anti-cancer ability.
(iv) in the presence of antibody, the FcγRIII (CD16) of NK cells binds to the Fc portion of antibody triggering the lysis of targeted cells. This phenomenon is also known as antibody-dependent cell-mediated cytotoxicity (ADCC).
Based on years of experience form Ex vivo expansion technology of immune cell, Medigen has developed a specialized methodology to expand and activate natural killer cells (called Magicell-NK), which have large number of cells, high purity and high cytotoxic ability, and does not use any non-human source ingredients and feeder cells.
After 14 ± 2 days of in vitro expansion, Magicell-NK consists of cells having a phenotype of CD3-CD56+ NK cells for more than 95%, which are considered as the high-purity NK cells. The overall cell survival rate is greater than 98%.
Ongoing clinical trials conducted in compliance with Good Clinical Practice (GCP) standards. Including autologous and allogeneic Magicell-NK for solid tumors.
Autologous Magicell-NK:
A phase I trial (CT-NK-11), “A Dose-Escalating Phase I Study to Determine the Safety, and Maximum Tolerated Dose/ Maximum Feasible Dose of Autologous ex vivo Expanded and Activated NK cell, Magicell-NK, Infusion for Colon Cancer post Resection”. The aim of this trial is to investigate the efficacy and safety of Magicell-NK as adjuvant therapy in patients with colon cancer post resection. [ClinicalTrials. gov Identifier: NCT05394714]
Allogeneic Magicell-NK:
A phase I/II trial (CT-ANK-21), “Dose-Finding Phase I Followed by a Phase II Study to Evaluate the Safety and Efficacy of Allogeneic NK-cell Therapy (ex vivo Expanded and Activated NK cell, Allogeneic Magicell-NK), as Adjuvant Therapy Combined with Chemotherapy in Patients with Pancreatic Ductal Adenocarcinoma (PDA) or Cholangiocarcinoma after Surgery”. The aim of the trial is to investigate the safety, tolerability and efficacy of allogeneic Magicell-NK in patients with post-operative PDA or cholangiocarcinoma.
